VITA IN-CERAM YZ CUBES FOR CEREC

K022996 · Vident · EIH · Oct 9, 2002 · Dental

Device Facts

• Record ID: K022996
• Device Name: VITA IN-CERAM YZ CUBES FOR CEREC
• Applicant: Vident
• Product Code: EIH · Dental
• Decision Date: Oct 9, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Vita In-Ciram YZ® Cubes for Cerec® is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crowns and bridges. Substructures of YZ® Cubes for Cerec® are machined using the Cerec 2, Cerec 3 and InLab systems.

Device Story

Vita In-Ceram YZ® Cubes are ceramic blocks used as dental substructures. The device is processed via CAD/CAM milling using Cerec 2, Cerec 3, or InLab systems. The resulting machined substructure serves as a framework for porcelain fused ceramic crowns and bridges. Used in dental clinics by dental professionals to fabricate custom restorations. The device provides a high-strength ceramic base for dental prosthetics, benefiting patients by enabling durable, aesthetic tooth replacement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Yttria-stabilized zirconia ceramic material. Form factor: pre-sintered cubes for CAD/CAM machining. Energy source: mechanical milling. Sterilization: not specified (standard dental material).

Indications for Use

Indicated for use as a substructure for porcelain fused ceramic fixed dental restorations, specifically crowns and bridges, in patients requiring dental restoration.

Regulatory Classification

Identification

Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## CT 0 9 2002

Ms. Barbara J. Lewandowski Regulatory Affairs Specialist Vident 3150 East Birch Street Brea, California 92821

Re: K022996

Trade/Device Name: Vita In-Cream YZ® Cubes for Cerec® Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: 76 EIH Dated: September 4, 2002 Received: September 9, 2002

Dear Ms. Lewandowski:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Ms. Lewandowski

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Patura Cuarite/for

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Koz2996

## 510 ( k) Number (if known):

Dev ce Nume: Vita In-Ceram YZ® Cubes for Cerec®

Indication: For Use:

Vita In-Ciram YZ® Cubes for Cerec® is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crowns and bridges. Sub tructures of YZ® Cubes for Cerec® are machined using the Cerec 2, Cerec 3 and InLat; systems.

## (PI EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Pasner

(Di vision S: gn-Off) Di ision o Dental, Infection Control and General Hospital Devices

511 (k) Nun ber

Prescription Use (P :r 21 Cl R 801.109). OR

Over-The Counter Use